Kornimate/medical-research-clean huggingface dataset:
evaluation of stricturing crohn's disease using digital holographic microscopy

Conditions: Inflammatory Bowel Diseases; Crohn Disease

Summary: crohn's disease (cd) patients, belonging to inflammatory bowel disease (ibd), frequently suffer from uncontrolled intestinal inflammation. this can lead to severe disease complications requiring hospitalization. up to 50% of all cd patients develope intestinal strictures. intestinal strictures can be subdivided into predominantly inflammatory and predominantly fibrotic types. this subclassification in different types of strictures is important for clinical decision making: patients with predominantly fibrotic strictures would undergo surgery or interventional endoscopic treatment and patients with predominantly inflammatory strictures would be treated anti-inflammatory. to determining the degree of fibrosis and inflammation in cd strictures remains difficult. digital holographic microscopy (dhm) is a new imaging approach belonging to the group of quantitative phase imaging. dhm enables stain-free quantitative phase contrast imaging and provides the determination of an refractive index which directly correlated to tissue density. this study aims to evaluate dhm for assessing the degree of fibrosis and inflammation in surgical specimen from patients with stricturing cd. the investigators collect full thickness surgical resection specimen from 29 patients with symptomatic cd strictures. more detailed, the investigators collect full thickness surgical resection specimen out of stenotic and non-stenotic bowel segments from each patient. for primary purposes, the investigators analyze the obtained tissue using dhm and compare differences of the refractive index, determined by dhm, between stenotic and non-stenotic parts of the intestinal wall. for secondary purposes, the investigators will correlate the findings made by dhm with a detailed analysis by a histopathologist using a scoring system (goldstandard) to determine the degree of fibrosis and inflammation in the samples.


Eligibility criteria:
inclusion criteria: * patients with a symptomatic intestinal crohn's disease stricture requiring surgery exclusion criteria: * patients \< 18 years * pregnancy * inability for an informed consent
risk factors, clinical characteristics and outcomes of acute infection with coronavirus 2019 (covid-19) in children

Conditions: Corona Virus Infection; Pediatric Cancer; Adult Children; Cancer

Summary: patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or sars-cov-2, that causes the disease known as covid-19. investigators do not know a lot about this virus, including all the ways it travels from person to person. investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future. primary objective * to determine the clinical characteristics and outcomes of covid-19 in children. * to characterize the clinical risk factors of covid-19 in children.. secondary objectives * to characterize the immunological risk factors and serologic response to sars-cov-2 infection in children.- to evaluate the duration of viral shedding in children. * to evaluate the duration of sars-cov-2 viral shedding in children. exploratory objective

nasal swabs will be collected from positive patient participants on day 0. timing of follow-up swabs will be guided by standard of care procedures. whole blood will be collected at days 0. follow-up blood sampling will be guided by standard of care procedures. samples will be stored at -80oc. nasal swabs and whole blood will only be obtained at the same time standard of care procedures are performed. if a patient is not getting a blood draw, no sample will be collected.

Eligibility criteria:
patient participant inclusion criteria: * less than 24 years old at the time of enrollment on study. * st. jude patients with laboratory confirmed covid-19. exclusion criteria: * na
steroid nasal irrigation for flavor evaluation and detection study

Conditions: Olfactory Disorder

Summary: the purpose of this research study is to examine the efficacy of a 12-week smell training intervention for participants with olfactory dysfunction following an infection of the upper respiratory tract.

olfactory dysfunction affects up to fifteen percent of the general population and can cause significant psychosocial distress including decreased appetite, reduced self-hygiene, and mood disturbances. this study aims to study the efficacy of smell training for patients with olfactory dysfunction following a viral upper respiratory tract infection. eligible participants will complete a 30-day course of budesonide nasal saline irrigation. participants who do not show improvement in their olfaction based on composite smell and taste tests will be eligible to receive a baseline resting-state fmri (rs-fmri) and complete a 12-week smell training intervention program. smell training involves participants smelling 4 odors (phenyl ethyl alcohol, eucalyptus, lemon, and eugenol) twice a day for 12 weeks. following completion of smell training, participants will undergo repeat smell and taste tests as well as rs-fmri to ascertain the efficacy of smell training.

Eligibility criteria:
inclusion criteria: * age between 18 and 70 * anosmia or hyposmia (upsit \<34 (male), upsit \<34 (female); sniffin' sticks threshold below 5.5) exclusion criteria: * inability to understand english * current smoker or history of smoking within the past 6 months * current nasal polyps * exposure to head and or/neck radiation * exposure to chemotherapy

Keywords: anosmia hyposmia intranasal steroid irrigation olfactory neuroplasticity olfactory training
iv cocaine abuse: a laboratory model - 4

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the effects of pergolide on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving in non-opiate dependent cocaine users.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence
bioavailability of blackberry juice anthocyanins

Conditions: Overweight and Obesity; Healthy

Summary: the main aim of this study is to evaluate the bioavailability of blackberry juice anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.

anthocyanins (ant), a particular class of flavonoids that can be found in red wine and red fruits, have been associated with relevant health benefits. it has become clear that the flavonoid bioactive forms in vivo are not necessarily those which occur in nature, but metabolites arising from them after absorption. therefore, it is important to identify which ant metabolites are responsible for their health benefits. since ant can prevent/treat some of the metabolic features of obesity it is also crucial to study whether ant bioavailability is not compromised in obesity. an anthropometric evaluation will allow the classification of subjects according to their body mass index (bmi). a complete medical examination including the assessment of clinical laboratory parameters will also be performed to characterize the health status of recruited subjects. before the beginning of the study, the last fecal sample obtained will be collected. urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting subjects. afterwards, each volunteer will consume 250 ml of blackberry juice with or without ethanol (visit 1 and 2) and blood samples will be collected 15, 30, 60 and 120 min after juice ingestion. another urine sample will be collected at 120 min. the first fecal sample obtained at least 6 h after juice ingestion will be collected. blood pressure (0 and 120 min) and glycaemic response (0, 15, 30, 60 and 120 min) will be measured in each visit. ethanol was added to the blackberry juice to mimic the concentration presented in red wine (12%). a thorough screening analysis for ant will be performed in plasma and urine samples collected from the volunteers at different time points. fecal samples will also be collected to evaluate the relationship between the presence of ant metabolites and the gut microbiota composition.

Eligibility criteria:
inclusion criteria: * men and women * age 18-40 years * bmi\>18 kg/m2 * willing and able to provide written consent exclusion criteria: * subjects with current or previous cvd, diabetes or other severe chronic disease * subjects under prescription of any chronic medication * pregnant or breast-feeding subjects * intake of antibiotics in the last 3 months prior to the beginning of the intervention * intake of red fruits or red wine in the last 24 h prior to the beginning of the intervention * subjects involved in any clinical or food study within the preceding month * subjects with a diagnosis of any digestive disease including functional bowel disorder such as ibs

Keywords: flavonoids anthocyanins blackberry juice bioavailability obesity
a study in subjects with perennial allergic rhinitis

Conditions: Perennial Allergic Rhinitis

Summary: the purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.


Eligibility criteria:
inclusion criteria: * have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing. * have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies. * have not started or had a change in immunotherapy regimen. exclusion criteria: * have a physical obstruction in the nose. * will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial. * have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy. * have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms. * have asthma of sufficient severity to require use of excluded medications. * have taken any medications excluded as listed in the protocol. * have a clinically significant acute or chronic disease or clinically significant laboratory abnormality. * are a current smoker, recent smoker or past smoker as defined in the protocol.
atp/amp challenge in healthy non-smokers, smokers, patients with asthma, and patients with chronic obstructive pulmonary disease (copd)

Conditions: Asthma; COPD; Smoking

Summary: in this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12 healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve asthma; and 30 patients with mild-moderate copd. each subject will have 1 screening visit (if necessary) and 2 study visits. at visits 2 and 3 the effects of adenosine 5'-triphosphate (atp) or adenosine 5'-monophosphate (amp) challenge, given in a random order, will be tested.

background: extracellular adenosine 5'-triphosphate (atp) stimulates vagal c and aδ fibers in the lung, resulting in pronounced bronchoconstriction and cough mediated by p2x2/3 receptors located on vagal sensory nerve terminals. we investigated the effects of nebulized atp on cough and symptoms in control subjects, healthy smokers, and patients with copd and compared these responses to the effects of inhaled adenosine, the metabolite of atp. methods: we studied the effects of inhaled atp and adenosine monophosphate (amp) on airway caliber, perception of dyspnea assessed by the borg score, cough sensitivity, and atp in exhaled breath condensate in healthy nonsmokers (n = 10), healthy smokers (n = 14), and patients with copd (n = 7). results: in comparison with healthy subjects, atp induced more dyspnea, cough, and throat irritation in smokers and patients with copd, and the effects of atp were more pronounced than those of amp. the concentration of atp in the exhaled breath condensate of patients with copd was elevated compared with that of healthy subjects. conclusions: smokers and patients with copd manifest hypersensitivity to extracellular atp, which may play a mechanistic role in copd.

Eligibility criteria:
inclusion criteria: 1. healthy non-smokers (n=12) * normal spirometry * forced expiratory volume in 1 second (fev1) reversibility of \< 15% after inhaled beta2-agonists\* 2. at risk (current smokers) (n=12)\* * normal spirometry, chronic symptoms (cough, sputum production) * fev1 reversibility of \< 15% after inhaled beta2-agonists\* (\* = global strategy for the diagnosis, management, and prevention of copd) 3. mild steroid-naïve asthma (n=30) * fev1 more than or equal to 80% 4. mild-moderate copd (n=30) * fev1 50-80% exclusion criteria: 1. pregnancy, breast-feeding, or planned pregnancy during the study. 2. fertile women not using acceptable contraceptive measures, as judged by the investigator 3. upper respiratory infection within the last 4 weeks 4. subjects who have received research medication within the previous one month 5. subjects unable to give informed consent 6. any psychiatric condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.

Keywords: healthy volunteers (smokers) healthy volunteers (non-smokers) asthma patients copd patients
validity of aortic pulse wave velocity in predicting the 6- minute walking test before major non-cardiac surgery

Conditions: Perioperative/Postoperative Complications; Surgery; Exercise Tolerance

Summary: methods: prospective observational study in adult patients requiring preoperative evaluation objectives: to determine the correlation between the aortic pulse wave velocity (aopwv) and the distance walked in the 6-minute walk test (6mwt) sample size: for a desired precision of estimate of ± 0.10 (95% confidence interval) around a postulated validity correlation coefficient of r = 0.70 (for an aopwv in the distance prediction of 6mwt) a sample of 100 patients. by allowing a 25% wear rate, a final sample size of 125 participants is required inclusion criteria: patients older than 18 years undergoing any surgery and who require pre-anesthesia statistical analysis if the variables have a normal distribution, the pearson correlation coefficient (r2) is used, which is between -1 and 1. where -1 indicates the highest possible negative linear relationship (increasing the value of a variable decreases the another), 0 that there is no association, +1 positive correlation. from 0.7 negative or positive, it is said that the association is strong. linear regression models of ordinary least squares will be applied to obtain the validity coefficient (r) and the standard error of the estimate (see): the typical error associated with the prediction the aopwv with the distance traveled in the 6mwd test in each individual patient. the analysis of the receiver operating characteristic curve (roc) will be used to derive cutoff points for an aopwv value for the prediction of a 6mwd less than 427 meters


Eligibility criteria:
inclusion criteria: * all patients older than 18 years undergoing elective surgery that receive a preoperative visit by anesthesiologists. exclusion criteria: * patients undergoing emergency surgery * patients under 18 years of age * patients who refuse to participate * patients unable to perform the 6mwt * claudication of the lower extremities and inability to maintain a constant pace of walking on level ground
technology-supported exercise therapy for patients with chronic low back pain

Conditions: Chronic Non-specific Low Back Pain

Summary: this clinical pilot trial will investigate the effects of technology-supported exercise therapy for chronic non-specific low back pain. patients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology. the technological system consists out of motion tracking sensors that register the movements and position of the lumbar spine.


Eligibility criteria:
inclusion criteria: * 18-65 y.o. * chronic non-specific low back pain, with or without leg pain * motor control impairment * sufficient knowledge of the dutch language to understand instructions exclusion criteria: * spinal surgery in the past * underlying serious pathologies (tumor, fracture, neurological diseases) * signs or symptoms of nerve root compression * pregnancy or less than 1 year post-partum * known allergy for tape
antiacne medications pseudotumor cerebri

Conditions: Optic Disc Swelling

Summary: the exact incidence of optic disc swelling and idiopathic intracranial hypertension in patients using antiacne medication is not known so far. the investigators hypothesize that swelling of retinal nerve fibre layer measured by optical coherence tomography is more frequent then assumed so far.

measurement of retinal nerve fibre layer using optical coherence tomography over a period of 6 to 9 months depending on exact antiacne medication.

Eligibility criteria:
inclusion criteria: * antiacne medication treatment indicated by dermatologist * age \> 18 years * contraception if indicated exclusion criteria: - age \< 18 years

Keywords: idiopathic intracranial hypertension optic disc swelling antiacne medication isotretinoin
novel intervention for amphetamine-type stimulants addiction

Conditions: Amphetamine Addiction

Summary: the repetitive transcranial magnetic stimulation (rtms) will be used to treat amphetamine-type stimulant (ats) addiction.

the glutamate and gaba deficits in prefrontal cortex play a vital role in ats addiction and relapse, and proposed repetitive transcranial magnetic stimulation (rtms) as a novel interventions. focused on evaluating glutamate/gaba functions in prefrontal cortex and functional connectivity with deep brain regions, neuropsychological tests, biochemical tests, magnetic resonance spectroscopy (mrs) and functional mri will be used to investigate the neurobiological mechanism of ats addiction and relapse. these methods will also be used to evaluate the efficacy of the novel intervention and investigate the mechanisms. the study will be very helpful to develop novel interventions in clinical practice and decrease ats-related harm for both the patients and their families.

Eligibility criteria:
inclusion criteria: * in accordance with the diagnostic and statistical manual of mental disorders-5 (dsm-5) for methamphetamine (ma) use disorders * dextromanual exclusion criteria: * have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc * have cognitive-promoting drugs in the last 6 months * other substance abuse or dependence in recent five years (except nicotine) * mental impairment, intelligence quotient (iq) \< 70 * mental disorders * physical disease

Keywords: amphetamine-type stimulants prefrontal-striatal circuits rtms glutamate/gaba motivational and cognitive intervention
efficacy and safety of fiasp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe, south america, and the united states of america (usa). the aim of the trial is to investigate efficacy and safety of fiasp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (visit 1) * current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, nph for at least 3 months prior to the screening visit (visit 1) * current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (su) or glinide or dipeptidyl peptidase-iv inhibitors and/or alpha-glucosidase inhibitors (agi) with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg * hba1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (oad) (sulphonylurea (su), glinide, dipeptidyl peptidase-iv (ddp-iv) inhibitors, alpha-glucosidase inhibitors (agi) combination group at the screening visit (visit 1) * body mass index (bmi) equal or less than 40.0 kg/m\^2 exclusion criteria: * any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (visit 1) * use of glucagon-like peptide-1 (glp-1) agonists and/or thiazolidinediones (tzd) within the last 3 months prior to screening (visit 1) * recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1)
a study treating participants with early axial spondyloarthritis (axspa) taking an intense treatment approach versus routine treatment

Conditions: Axial Spondyloarthritis

Summary: a study comparing a treat-to-target (t2t) intense treatment approach with routine treatment (standard of care \[soc\]) in reducing disease activity in participants with axial spondyloarthritis (axspa).


Eligibility criteria:
inclusion criteria: * signed written informed consent before start of study-related assessments or procedures * diagnosis of axspa (either ankylosing spondylitis or non-radiographic axspa) and fulfilling the assessment of spondyloarthritis international society (asas) classification criteria for axspa * participants aged ≥ 18 years * disease duration \< 5 years * participants must have a baseline disease activity as defined by an asdas ≥ 2.1 or a bath as disease activity index (basdai) ≥ 4 * nsaid-naive or not treated with the maximal recommended nsaid dose during the last 2 weeks prior to the baseline visit * participants must never have failed a nsaid taken at maximal recommended dose for 2 weeks or more. exclusion criteria: * contraindications for nsaids or tumor necrosis factor (tnf) blocker according to local labeling * if entering the study on concomitant nsaids, participants taking the maximal recommended dose during the last 2 weeks prior to the baseline visit or have failed or developed intolerance to a nsaid taken at maximal recommended dose for 2 weeks or more at any time * prior exposure to any anti-tnf therapy; any biologic therapy with a potential therapeutic impact on spa, or participant has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the baseline visit.

Keywords: axial spondyloarthritis humira